The Influence of Different Hydrocortisone Replacement Doses on the Partitioning and Flexibility of Ectopic Lipids in Patients With Corticotropic Hypopituitarism

• Status: Terminated
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims at assessing the effect of today's standard of hydrocortisone dosage versus previous hydrocortisone dosage on flexibility and partitioning of ectopic lipid depots (IMCL and IHCL) after a standardised fat load followed by a short-term aerobic exercise in patients with corticotropic pituitary insufficiency.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Treatments: Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate

Criteria

Inclusion Criteria:

• Written informed consent

• Male and female patients

• Corticotropic pituitary insufficiency

• Capable to exercise during 120 minutes on a bicycle

• Normal ECG during ergometry

Exclusion Criteria

• Concomitant medication with NSAID, anticoagulants, digoxin, salbutamol, anticonvulsants, cholinesterase inhibitor, pancuronium

• Abnormal liver, renal or thyroid function, heart failure

• Hemophilia

• Diabetes mellitus

• Severe dyslipidemia

• Active neoplasia

• Women who are pregnant or breast feeding

• Intention to become pregnant during the course of the study

• Lack of safe contraception

• Known or suspected non-compliance

• Drug or alcohol abuse

• Inability to follow the procedures of the study

• Participation in another study with investigational drug within the 30 days preceding and during the study

• Previous enrolment into current study

• Enrolment of the investigator, his/her family members, employees and other dependent persons

• Inability to exercise

• Contraindications to exposure to a 3 T magnetic field

• Major depression, psychosis, claustrophobia